Anxiety and stress are common and costly problems afflicting American adults and are a leading reason for using complementary and alternative medical (CAM) therapies. Although massage is one of the most popular CAM treatments for anxiety, its effectiveness has never been rigorously evaluated for a diagnosed anxiety disorder. This study lays the groundwork for a full-scale randomized clinical trial to evaluate the effectiveness, safety, and costs of massage for generalized anxiety disorder (GAD), a common and frustrating condition that often presents with many somatic symptoms, including muscle tension. In Phase I of this project, we will develop and pre-test key components of such a trial, including participant selection criteria and the treatment protocols for the massage and comparison groups. In Phase II, we will use the components developed during Phase I to conduct a pilot trial evaluating the effectiveness and safety of massage for GAD. We will randomize 75 persons with GAD to therapeutic massage (n=25) or to one of two control groups ("thermotherapy" or a "relaxing environment"; n=25 for each). We will evaluate the effect of massage on anxiety-related symptoms and dysfunction, quality of life, and costs of GAD-related provider visits by comparing changes in these outcomes in the massage and control groups at the end of treatment and at 6 months. The pilot study will permit us to identify and address unanticipated problems with the study design, outcome measures, and treatment protocols; to estimate the samples sizes needed for an adequately-powered full-scale trial and the related recruitment period that would be required; and to obtain preliminary estimates of the effectiveness and safety of massage for GAD. At the conclusion of this project, we will be well positioned to prepare a competitive grant proposal for a full-scale trial evaluating the effectiveness of massage as a treatment for persons with GAD. RELEVANCE: Although Americans commonly visit massage therapists for anxiety and stress , no studies have evaluated massage as a treatment for a diagnosed anxiety disorder. By first developing a series of massage treatments for generalized anxiety disorder and then evaluating these treatments in a pilot study, this study represents the first step toward filling this important gap in our knowledge. [unreadable] [unreadable] [unreadable]